(30 days)
No
The device description and performance studies focus on the mechanical and material properties of a surgical trocar, with no mention of AI or ML capabilities.
No
The device is a surgical trocar used to establish a pathway for instrumentation during endoscopic procedures, not to treat or diagnose a disease.
No
The device is described as a surgical trocar used to establish a pathway for instruments during endoscopic procedures, not to diagnose a condition.
No
The device description clearly outlines a physical, single-use, disposable surgical trocar made of plastic components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "establish a pathway for instrumentation and permit maintenance of insufflation" during endoscopic surgical procedures. This is a surgical tool used in vivo (within the body) to facilitate a surgical procedure.
- Device Description: The description details a physical device used for creating an access point into the body. It does not involve the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing diagnostic information
- Using reagents or assays
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a surgical instrument, not a diagnostic device.
N/A
Intended Use / Indications for Use
The ECI Sabre BTM Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.
Product codes
FBQ, KOG
Device Description
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.
Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following biocompatibility tests were performed on the proposed device:
- Cytotoxicity Test 1.
-
- USP Intracutaneous Toxicity Test
- Guinea Pig Maximization (Kligman) Sensitization Test 3.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5090 Suprapubic urological catheter and accessories.
(a)
Identification. A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.(b)
Classification. (1) Class II (performance standards).(2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
APR -1 199
Endosconic Concents Inc. 510(k) Premarket Notification
510(k) Summary
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, Endoscopic Concepts Inc. is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." Apple Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Device Trade Name: | Sabre BTTM Blunt-Tip Surgical Trocar | |
|---|---|---|
| Owner/Operator: | Endoscopic Concepts Inc. | |
| 1191 North Federal Highway | ||
| Delray Beach, FL 33483 | ||
| FDA Registration # 9011363 | ||
| Manufacturing Site: | Contract manufacturer selected and controlled by: | |
| Endoscopic Concepts Inc. | ||
| 2 Maple Street | ||
| P.O. Box 375 | ||
| Mendon, MA 01756 | ||
| FDA Registration # 1058828 | ||
| Device Generic Name: | Laparoscopic trocar/cannula | |
| Classification: | According to Section 513 of the Federal Food, Drug, and | |
| Cosmetic Act, the device classification is Class II, Performance Standards (21 | ||
| CFR 884.1720). | ||
| Predicate Devices: | Sabre Ultimate Shielded Trocars | |
| Manufactured and Distributed by: | ||
| Endoscopic Concepts Inc. | ||
| Mendon, MA 01756 | ||
| K943976 | TroGardTM Blunt Tip Trocar System | |
| Manufactured and Distributed by: | ||
| ConMedTM Aspen Surgical Systems | ||
| Utica, NY 13501 | ||
| K933456 |
Product Description:
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is a single-use, disposable device consisting of a smooth (non-threaded), plastic cannula which is available with an inner diameter of 5, 10 or 12mm. The blunttipped trocar is a multi-piece assembly consisting of a plastic handle, and a smooth, rounded plastic tip. This device is intended for use in laparoscopic procedures where the initial incision has been made surgically. The trocar's blunt, atraumatic tip gently moves aside the internal viscera when the device is inserted through the incision site.
Because the OD of the cannula is non-threaded, the device is supplied with an adjustable plug or "olive" which is secured to the patient's skin using sutures placed through the device's "tie posts." The olive has a silicone inner lock ring which firmly grasps the cannula OD when the device is manually tightened.
Indications for Use:
The ECI Sabre BTM Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and permit maintenance of insufflation.
1
Biocompatibility:
The following biocompatibility tests were performed on the proposed device:
- Cytotoxicity Test 1.
-
- USP Intracutaneous Toxicity Test
- Guinea Pig Maximization (Kligman) Sensitization Test 3.
Conclusion:
Coucideson.
Based on the indications for use, technological characteristics and performance testing, the ECI Sabre BT™ Blunt-Tip Surgical Trocar has been shown to be safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three stripes on its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the edge of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 1 1998
Ms. Pamela L. Papineau Consultant for Endoscopic Concepts, Inc. c/o Delphi Medical Device Consulting 50 Brewster Street Pawtucket, Rhode Island 02860
Re: K980804 Trade Name: Sabre BT™ Blunt Tip Surgical Trocar Regulatory Class: II Product Code: FBQ and KOG Dated: February 13, 1998 Received: March 2, 1998
Dear Ms. Papineau:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set . . forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Ms. Papineau
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page
510(k) Number (if known): K9810804
Device Name: ECI Sabre BT™ Blunt-Tip Surgical Trocar
Indications for Use:
The ECI Sabre BT™ Blunt-Tip Surgical Trocar is indicated for use during endoscopic surgical procedures to establish a pathway for instrumentation and to permit maintenance of insufflation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| --------------------- |
| Division of General Restorative Devices | |
|---|---|
| 510(k) Number | K980804 |
| Prescription Use | X | OR | Over-the-Counter Use ______ |
|---|---|---|---|
| (Per 21 CFR 801.109) |